1
Clinical Trial Protocol
Iranian Registry of Clinical Trials
06 Nov 2022
Effect of Riluzole on cognitive function of patients with mild Alzheimers disease: a double-blind randomized clinical trial, placebo-controlled
Protocol summary
Study aim
Study of the effect of Riluzole on the cognitive function of patients with mild Alzheimer's disease
Design
This study is a randomized clinical trial trial, placebo- controlled, double-blind that will be conducted between 2018 -2019. study population is the patient with mild Alzheimer's disease, aged 60-80 years old. A total of 48 patients are randomly divided into two equal groups of placebo and main drug group. Randomization will be done by using the four block size.
Settings and conduct
Patients referred to Shariati Hospital's neurology clinic and private neurology clinic who are eligible for study are randomly divided into two groups of main drug and placebo. The intervention group received 50 mg oral Riluzole tablets twice a day for three months and the placebo group received in the same way . Patients will be evaluated in terms of disease progression, cognitive function, and memory performance on day one and 90th of study . They are also considered for drug side effects during the study. Patients and the main investigators who measure the outcomes will be blinded to The type of medication .
Participants/Inclusion and exclusion criteria
Patients with mild Alzheimer's disease aged 60-80 years old who received one of the FDA approved
anticholinesterase drugs for Alzheimer's treatment from three months ago, will be included in the study, and patients with a history of other types of dementia and other neurological diseases and major psychiatric disorders, and history of hypertension and Uncontrolled diabetes will not be included in the study
Intervention groups
Intervention includes the administration of oral tablets of Riluzole in intervention group and the administration of placebo tablets in the control group.
Main outcome variables
Evaluation of cognitive function; memory performance
and progression of Alzheimer's disease are the main outcomes of the study
General information
Reason for update Acronym
IRCT registration information
IRCT registration number: IRCT20100126003181N4 Registration date: 2018-03-01, 1396/12/10
Registration timing: prospective
Last update: 2018-03-01, 1396/12/10 Update count: 0
Registration date 2018-03-01, 1396/12/10 Registrant information
Name
Zahra Mokhtari
Name of organization / entity
Otorhinolaryngology research center, Tehran university of medical sciences
Country
Iran (Islamic Republic of) Phone
+98 21 6676 0269 Email address
zmokhtari@razi.tums.ac.ir Recruitment status
Recruitment complete Funding source
Expected recruitment start date 2018-04-21, 1397/02/01
Expected recruitment end date 2019-10-23, 1398/08/01 Actual recruitment start date
empty
2 Actual recruitment end date
empty
Trial completion date empty
Scientific title
Effect of Riluzole on cognitive function of patients with mild Alzheimers disease: a double-blind randomized clinical trial, placebo-controlled
Public title
Effect of Riluzole on Alzheimer's Disease Purpose
Treatment
Inclusion/Exclusion criteria Inclusion criteria:
Having of mild type of Alzheimer's Disease Receiving one of the anticholinesterase drugs for treating Alzheimer's from three months ago aged between 60-80
Exclusion criteria:
Having any other type of Dementia Any history of using Memantine or Riluzole History of using medications with glutamatergic interaction History of alcohol and opium abuse History of diseases such as Parkinson's disease, epilepsy, stroke, high blood pressure, uncontrolled diabetes, MS, mental retardation, CNS tumors, Huntington, subdural Hematoma, history of major psychiatric diseases History of severe head trauma that results in loss of consciousness
Age
From 60 years old to 80 years old Gender
Both Phase
3
Groups that have been masked Participant
Care provider Investigator Outcome assessor Sample size
Target sample size: 48
Randomization (investigator's opinion) Randomized
Randomization description
Randomization will be done by 4 block size.
Blinding (investigator's opinion) Double blinded
Blinding description
Since the placebo is exactly the same as the original medicine, and when informed consent is informed, the patient is randomly assigned to one of the drug or placebo groups, so the patient is not aware of the type of medication. Also, the main investigator who examined the initial outcome will be blind to patient's drug type, because the allocation is done by Secretary of the clinic.
Placebo Used Assignment
Parallel
Other design features
Secondary Ids empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Vice Chancellor for research, Tehran University of Medical Sciences, Ghods St, Keshavarz Blvd City
Tehran Province
Tehran Postal code
1417653761 Approval date
2018-02-03, 1396/11/14
Ethics committee reference number IR.TUMS.MEDICINE.REC.1396.4403
Health conditions studied
1
Description of health condition studied Alzheimer Disease
ICD-10 code G30
ICD-10 code description Alzheimer's disease
Primary outcomes
1
Description
Cognitive function assessment Timepoint
The first day and the 90th day of study Method of measurement
Using the test of Mini Mental State Examination (MMSE)
2
Description
Assessment of memory Timepoint
The first day and the 90th day of study Method of measurement
Using the test of Delayed recall test
3
Description
Assessment of disease progression Timepoint
3 The first day and the 90th day of study
Method of measurement
Using the Functional Assessment Staging Tool (FAST)
Secondary outcomes
1
Description Drug side effect Timepoint
fourth week
Method of measurement ask from patient
Intervention groups
1
Description
Intervention group: Riluzole 50 mg oral tablet twice daily for three months
Category
Treatment - Drugs
2
Description
Control group: Placebo (similar to the original drug) oral twice daily for three months
Category Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center Shariati hospital
Full name of responsible person Dr. Farzad Fatehi
Street address
North Kargar Ave.Shariati hospital City
Tehran Province
Tehran Postal code
1411713135 Phone
+98 21 84901 Email
zmokhtari@razi.tums.ac.ir
2
Recruitment center
Name of recruitment center private Clinic of Neurology Full name of responsible person
Dr.Maryam Norozian
Street address
Shahrak e Gharb .Tehran City
Tehran Province
Tehran Postal code
1417653761 Phone
+98 21 8809 4303 Email
zmokhtari@razi.tums.ac.ir
Sponsors / Funding sources
1 Sponsor
Name of organization / entity
Tehran University of Medical Sciences Full name of responsible person
Dr. Mohammad Ali Sahraeian Street address
Ghods St., Keshavarz Blvd ,Tehran City
Tehran Province
Tehran Postal code
1417653761 Phone
+98 21 8163 3628 Email
rcc@tums.ac.ir Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences Proportion provided by this source
100
Public or private sector Public
Domestic or foreign origin Domestic
Category of foreign source of funding empty
Country of origin
Type of organization providing the funding Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences Full name of responsible person
Dr.Zahra Mokhtari Position
PhD of Medical Physiology
4 Latest degree
Ph.D.
Other areas of specialty/work Physiology
Street address
Otorhinolaryngology Research center ,Amiralam hospital ,
City Tehran Province
Tehran Postal code
1145765111 Phone
+98 21 6676 0269 Fax
+98 21 6676 0269 Email
zmokhtari@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity Tehran University of Medical Sciences Full name of responsible person
Dr. Zahra Mokhtari Position
یژﻮﻟﻮﯾﺰﯿﻓ ﯽﺼﺼﺨﺗ یﺮﺘﮐد Latest degree
Ph.D.
Other areas of specialty/work Physiology
Street address
Otorhinolaryngology Research center ,Amiralam hospital,North Saadi st.
City Tehran Province
Tehran Postal code
1145765111 Phone
+98 21 6676 0269 Email
zmokhtari@razi.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences Full name of responsible person
Dr. Zahra Mokhtari Position
ﯽﮑﺷﺰﭘ یژﻮﻟﻮﯾﺰﯿﻓ ﯽﺼﺼﺨﺗ یﺮﺘﮐد Latest degree
Ph.D.
Other areas of specialty/work Physiology
Street address
و شﻮﮔ تﺎﻘﯿﻘﺤﺗ ﺰﮐﺮﻣ ،ﻢﻠﻋاﺮﯿﻣا نﺎﺘﺳرﺎﻤﯿﺑ، ﯽﻟﺎﻤﺷ یﺪﻌﺳ نﺎﺑﺎﯿﺧ ﯽﻨﯿﺑ و ﻖﻠﺣ
City Tehran Province
Tehran Postal code
1145765111 Phone
+98 21 6676 0269 Email
zmokhtari@razi.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD) Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code Not applicable Data Dictionary Not applicable
